Fda regulatory jobs in San Diego, CACreate job alerts

Regulatory Affairs Manager Location: San Diego, CA (Onsite) Salary Range: $145,000 - $165,000 Job Summary BioPhase is seeking a Regulatory Affairs Manager to lead regulatory strategy and compliance for in vitro diagnostic (IVD) products. This role oversees regulatory submissions, market au...

Company Description SOLVD Health is dedicated to preventing disease by making actionable and contextual health information accessible to everyone through Patient Intelligence. The company believes in bringing about real, lasting change in patients' lives by addressing the biggest challenges in h...

The Regulatory Affairs Manager will manage a team of three (3) technical staff to develop regulatory plans for products, to prepare regulatory submissions such as 510(k)’s and EU IVDR Technical Documentation to manage communications with Regulatory Agencies e.g. FDA, EU Notified Bodies and Health...

Role: Validation Specialist, D365 (Supply Chain Modules) REMOTE Duration: 3+ Months (extendable up to 12 Months) Overview: Our client is seeking a D365 Validation Specialist to support the validation of Microsoft Dynamics 365 (D365) Supply Chain modules in a GxP-regulated environment. This...

About Codera Codera is a Tang Capital company that provides in-house end-to-end drug development capabilities for its portfolio companies. Founded in 2002, Tang Capital is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize phar...

A Biopharmaceutical organization in the San Diego area is seeking a highly experienced Sr. Compliance Associate to join its Quality team. This individual will play a key role in ensuring compliance with internal and external quality standards, particularly in preparation for and during audits and...

Principal Clinical Data Manager Location: Onsite – San Diego, CA Employment Type: Full-time Job Description: We are seeking an experienced Principal Clinical Data Manager to lead data management activities for our Phase III obesity clinical trials. This role requires extensive CRO oversight t...

We are looking for a talented Regulatory Affairs Manager to join our client's team and play a crucial role in bringing new products to market. This role will be responsible for leading the regulatory strategy and managing submissions for new product launches for our client's cardiovascular medica...

Principal Investigator / Clinical Research Physician About the Role: The Principal Investigator (PI) will oversee all aspects of trial execution, ensuring adherence to ICH/GCP guidelines, FDA regulations, and study protocols. The position focuses on participant safety, data integrity, and...

Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutio...

PRINCIPAL MEDICAL AND REGULATORY WRITER Excellent opportunity to join a newly formed Medical Writing team at a well-established biotech company in San Diego County. The Principal Medical and Regulatory Writer will be assigned to projects that require advanced regulatory writing and requires exte...

Position: Staff Scientist, Clinical Development Function: Clinical Development and Operations Company: Phanes Therapeutics, Inc. Location: San Diego, CA Phanes Therapeutics is a clinical stage biotech company focused on innovative discovery research and clinical development in oncology. Th...

Our client is currently the leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company, which has over 50 years of experience and expertise, provides products for research, clinical development and commercial application to pha...

ASSISTANT DIRECTOR-ANALYTICAL DEVELOPMENT & QUALITY CONTROL Seeking an experienced analytical chemist to join our QC & Analytical Development group at the Assistant Director level. The ideal candidate will be a self-starter, familiar with a broad range of analytical techniques, possess a stro...

Job Title: Clinical Project Manager Location: San Diego, CA Schedule: Remote and/or Hybrid Company Overview: Contineum Therapeutics (Nasdaq: CTNM) is a clinical-stage biopharmaceutical company pioneering novel, oral small molecule therapies for NI&I indications with significant unmet need....

A biotech client is seeking a highly experienced Director of Systems Engineering to lead the systems engineering process from concept to production, ensuring the design, development, integration, verification, and manufacturability of a combination device drug delivery platform meet all technical...

Role: Staff Quality Engineer Contract W2 Only Location: San Diego, CA The Sr. Staff Quality Engineer is a contract role that will be responsible for leading a project to improve the Quality and compliance of the Dispensing Implementation process. This role will work with the Dispensing Impl...

A cutting-edge biotech client in San Diego is looking to hire a Technical Program Manager to join their team. This person should have experience leading programs and effectively working with the cross functional program teams, to facilitate the development and completion of design control documen...

QA Process Validation Specialist – BioPhase Department: Quality Assurance 📍 Location: San Diego (Fully Onsite) 💰 Salary Range: $80,000 - $88,000 Job Summary: BioPhase is seeking a QA Process Validation Specialist to support pharmaceutical manufacturing processes in a highly regulated en...

Job Title: Quality Specialist CFNJP00050894 Location: San Diego, CA 92121 Duration: 12 Months Responsibilities: Knowlegde of FDA , CFR 820, ISO undertsanding of rick profircinet in exel and word. Making sure the service records are filled out correctly .• Key member of the Dispensing Serv...

Job Description JOB SUMMARY The Sr. Director, Head of Regulatory Affairs will be responsible for overseeing all regulatory affairs activities related to the development of innovative small molecules for the treatment of cancer. This role will involve directing regulatory submissions, ensuring co...

Job Description Job Description: We are seeking a highly motivated and qualified individual to join ADARx Pharmaceuticals as an Executive Director of Legal to lead and manage all legal aspects of the company’s operations. This individual will play a critical leadership role in supporting corpora...

Job Description Job Description: We are seeking an experienced, collaborative, strategic physician to build and realize the vision for the Company’s portfolio by helping build and execute clinical trial strategy. This is a leadership role that requires proven abilities to drive both strategic in...

Job DescriptionSalary: Who Are We? Founded in 1997 and built upon 27+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diegos Top Workplaces, we take pride in maintaining a company culture t...

Job DescriptionSalary: About Akoya Biosciences, Inc. As The Spatial Biology Company, Akoya Biosciences mission is to bring context to the world of biology and human health through the power of spatial phenotyping. The company offers comprehensive single-cell imaging solutions that allow resear...

Job Description JOB SUMMARY Under the supervision of the Executive Director DMPK/Clinical Pharmacology, the successful candidate will lead DMPK efforts on discovery and preclinical development programs at Iambic. This role involves setting clear objectives, designing and implementing DMPK studie...

Job Description Job Title: Software Engineer III | Sr. Connectivity Engineer Location: San Diego, CA – 100% onsite – local candidates only Period: 08/26/2024 to 02/28/2025 Hours/Week: 40 hours – hours over 40 will be paid at time and a half Rate: $60 - $70/hour Contract Type: W-2 only, temp to hi...

Job Description At Modular Medical, our goal is to simplify diabetes management, ensuring that everyone has access to the superior care that insulin pumps offer. We believe that managing diabetes should be empowering, not intimidating. You shouldn’t have to be a tech expert or a math genius to ta...

Job Description Job Description: We are seeking a highly motivated and qualified individual to join our Clinical Department as an in-house CRA and work as part of a team to drive success. Ideal candidates will be self-motivated, independent, committed to the generation of high-quality data withi...

Job Description About Capricor Therapeutics Capricor Therapeutics is a pioneering biotechnology company dedicated to transforming the lives of patients through groundbreaking therapies for severe and complex diseases. Focused on advancing cell and exosome-based technologies, we aim to address cr...

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical...

Job DescriptionSummary We are seeking a motivated individual to join our Clinical Department as an In-House Clinical Research Associate (CRA). Ideal candidates will be self-driven and committed to generating high-quality data within an innovative research team. The CRA will support the administra...

Job DescriptionChief Medical Officer (CMO) San Diego, CA $350,000 - $470,000 About the Role BioPhase is partnering with a cutting-edge biotech company to hire a Chief Medical Officer (CMO). This executive will lead clinical development strategy, oversee regulatory efforts, and represent the compa...

Job DescriptionDescription: The Chief Medical Officer, “CMO” will work as a strategic partner with other members of the senior executive team to develop and advance their clinical development strategy and drive the clinical research vision and regulatory roadmap for the company. The CMO will have...

Job Description Who is CorDx？ CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical...

Job DescriptionSalary: $260k-$320k Job Title: Executive Director (ED) or Vice President (VP) of CMC Drug Product Location: Southern California - Orange County or San Diego Salary Range: $260k-$320k based on experience About the organization: The organization is advancing a best-in-class dr...

Job DescriptionSalary: About Artiva: Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead product candidate, AlloNK, is a non-genetically modified, ...

Job Description ARS Pharmaceuticals is a commercial pharmaceutical company, passionate about improving patients' lives. We are launching neffy®, an intranasal epinephrine product for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that cou...

Job Description Capricor Therapeutics is a biotechnology company dedicated to developing transformative therapies for rare diseases, with a primary focus on Duchenne muscular dystrophy (DMD). We are pioneers in cell therapy and exosome-based technology, leveraging our proprietary StealthX™ platfo...

Job DescriptionSalary: About Artiva: Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead product candidate, AlloNK, is a non-genetically modified, ...

Job Description At Modular Medical, we are dedicated to transforming diabetes care through innovative technology. As we work towards launching our first insulin pump product, we are committed to providing patients with reliable and user-friendly solutions. We are seeking a talented and experience...

Job Description ClearNote Health develops clinical tests to detect cancer when it can still be cured. We are searching for a LIMS Administrator/Developer to join the San Diego team. This role will be responsible for the administration, configuration, customization, and maintenance of the LIMS sof...

Job DescriptionSummary Reporting to the Sr. Director of Clinical Operations, the Clinical Trials Manager is responsible for overseeing and executing the operational aspects of one or more clinical studies from protocol development through database lock. This role ensures the timely conduct of cl...

Job Description Position Description We are seeking an entrepreneurial Medical Immunologist to assume the role of Senior Medical Director for our innovative allogeneic regulatory T cell therapy programs. The ideal candidate thrives in a dynamic, fast-paced startup environment and is eager to e...

Job Description Position: Preclinical Surgical Specialist FLSA Status: Exempt Salary Range: $100,000 - $120,000 / yr Location: Carlsbad, CA Job Overview: Pharmaron is seeking a highly skilled Surgical Specialist to join our innovative Medical Device team in Carlsbad, CA. This hands-on role f...

Job DescriptionSalary: About Artiva: Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artivas lead product candidate, AlloNK, is a non-genetically modified, ...

Job Description PURPOSE Ensure suitability of plasmapheresis donors, through the use of the SOP, current FDA and State guidelines, OSHA, CLIA, cGMP, and all internal company procedures. General Requirements – Adhere to all Standard Operating Procedures, Current Good Manufacturing Practic...

Job Description We are looking for an experienced Quality Manager to ensure that our products and services meet all necessary requirements before they reach the consumer. The Quality Manager, or Quality Assurance Manager, will inspect the final product to make sure it has been built with complian...